Summary

The planned research will adapt an intervention of known efficacy to target a new outcome of
significant importance to public health. Specifically the Community Reinforcement and Family
Training (CRAFT) procedures will be adapted, from reinforcing treatment entry, to
reinforcing treatment retention and HIV risk behavior reduction in persons with opioid
dependence who receive a Buprenorphine taper detoxification. The research plan includes
three phases: 1) development of a manual guided therapy, 2) development of therapist
training and fidelity measures and 3) a randomized pilot evaluation with 52 patients
receiving either the new CRAFT treatment or treatment as usual.

Study Design

Community Reinforcement and Family Training for Retention in Treatment and Recovery and Reduction of HIV Risk Behavior (CRAFT-T)

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The Community Reinforcement and Family Training for Treatment Retention and HIV Risk Reduction treatment (CRAFT-T) was be developed in phase 1 and 2 of the current study and consists of twelve manual-guided weekly one-hour individual sessions for the concerned significant other and 2 one hour sessions for the identified patient. The intervention also allows for up to two additional sessions (total of 14 visits) to help arrange re-entry into substance abuse treatment when needed. The identified patient receives this intervention in addition to the usual services at the drug treatment program (Maryhaven).

The portion of available treatment sessions attended during each assessment period including,

time frame:
6 months

Substance use (defined as days of self-reported substance use, with partial confirmation by urinalysis and breathalyzer) during the active study phase and through the 3 month and 6-month follow-ups.

time frame:
6 months

The identified patient's substance use as reported by the CSO (collateral reports of drug use).

time frame:
6 months

Changes in concerned significant other and identified patient function as measured using the Brief Symptom Inventory. Specifically, the Global Severity Index (GSI) score.

time frame:
6 months

Concerned significant other and identified patient's relationship satisfaction (the score on the General Happiness Scale of the RHS).

time frame:
6 months

Marital satisfaction as measured by the KMS for the sub-sample of concerned significant others who are married to their identified patient's.

time frame:
6 months

The identified patient's (IP) retention in any substance abuse specific intervention, including self-help, as reported by the IP on the Treatment tracking form.

time frame:
6 months

The identified patient's retention in any substance abuse specific intervention, including self-help, as reported by CSO on the Treatment Tracking form.

time frame:
6 months

Identified patient (IP) attendance at self-help groups (i.e., AA, NA, CA) (defined as the number of times that the IP has attended a self-help group as assessed on the Treatment Services Review).

time frame:
6 months

Identified patient's use of professional services, other than substance abuse treatment, as reported on the TSR.

time frame:
6 months

Concerned significant others satisfaction with treatment as measured by the Participant Satisfaction Form.

time frame:
3 months

Identified patient's satisfaction with treatment as measured by the Participant Satisfaction

time frame:
1 month

Eligibility Criteria

Male or female participants at least 18 years old.

Concerned Significant Other Inclusion Criteria: 1)be a first-degree relative, spouse, or
intimate partner, or plan to live with the IP following the IP's detoxification, must plan
to have contact with the IP at least 40% of the first 90 days post randomization, 2)be age
18 or older, 3)live within approximately 60 miles of Maryhaven, )be willing to participate
in the protocol (i.e., to be randomized to treatment, to attend regular treatment
sessions, to have their sessions audio taped, etc.), 5)be willing to sign a
HIPAA-compliant release(s) of information to allow research staff access to any
information collected from this subject during the study. Such staff may include RAs,
therapists, supervisors, data managers, statisticians, QA personnel, etc., 6)be able to
understand and provide written informed consent in English, 7)express desire to assist the
IP with treatment retention and HIV risk behavior reduction.
Concerned Significant Other Exclusion Criteria: 1) are unlikely to be available to
complete the entire protocol (e.g., plan to relocate, intention to not continue if
assigned to a perceived unattractive arm of the study), 2)have a condition (e.g., medical
complications, psychiatric problems, etc.) that would necessitate inpatient treatment or
would make study participation difficult, 3)have engaged in domestic violence or assault
within the previous year or have a history of severe violence (i.e., use of a weapon or
violence leading to a hospitalization). For the purposes of the present protocol, domestic
violence is defined as any physical abuse between intimately involved partners, roommates,
or family members, 4)are currently at risk for suicide as evidenced by presence of at
least one of the following; a) a history of a suicide attempt(s) and current suicidal
ideation, b) current suicide ideation including recurrent thoughts of suicide with
intention to harm themselves, c) persistent or recurring desire to die, d) a plan to harm
themselves, e) indication that they would not take steps to save their own life, 5)have
been the victim of severe domestic violence (i.e., use of a weapon or violence leading to
a hospitalization) by the IP.
Identified Patient Inclusion Criteria: 1)be a first-degree relative, spouse, or intimate
partner of the CSO, or someone who lives with the CSO, 2)be age 18 or older, 3)be
currently enrolled in the BUP/NX 13-day taper protocol in Maryhaven's detoxification
program, 4)intend to continue with outpatient treatment at Maryhaven, 5)be willing to
participate in the protocol (i.e., to be randomized to treatment, to attend regular
treatment sessions, to have their sessions audio taped, etc.), 6)be willing to sign a
HIPAA compliant release(s) of information to allow research staff access to any
information collected from this subject during the study. Such staff may include RAs,
therapists, supervisors, data managers, statisticians, QA personnel, etc., 7)be able to
understand and provide written informed consent in English, and 8)have a substance use
disorder assessed by the Structured Clinical Interview for DSM-IV.
Identified Patient Exclusion Criteria: 1)have engaged in domestic violence or assault
within the previous year or have a history of severe violence (i.e., use of a weapon or
violence leading to a hospitalization), 2)have a history of a suicide attempt(s)within the
past year or current suicidal ideation, 3)are currently at risk for suicide as evidenced
by presence of at least one of the following; (same as CSO suicide lethality criteria
above), 4)have a condition (e.g., medical complications, or psychiatric problems other
than substance abuse, etc.) that would necessitate residential/inpatient treatment or
would make study participation difficult, 5)under a court order to enter and remain in
treatment program.

Additional Information

Official title

A Stage 1 Study of Community Reinforcement and Family Training for Treatment Drug Abuse Treatment Retention/HIV Risk Reduction

Principal investigator

Gregory S. Brigham, Ph.D.

Trial information was received from ClinicalTrials.gov and was last updated in August 2012.

Information provided to ClinicalTrials.gov by University of Cincinnati.